Database updated: 15 April 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18028 |
| Brand Name: | S&N Birmingham Hip Resurfacing (BHR) Head |
| Model: | 74121138, 74123140, 74121142, 74123144, 74121146, 74123148, 74121150, 74123152, 74121154, 74123156, 74121158, 74123160, 74123162 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Smith & Nephew Surgical Ltd Unit A 36 Hillside road Wairau Valley AUCKLAND 0760 |
| Contact Information: | 0800 657 799 |
| Manufacturer: | Smith & Nephew Orthopaedics Ltd |
| Brand Name: | S&N Birmingham Hip Resurfacing (BHR) Acetabular Cup |
| Model: | 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122050, 74122152, 74120152, 74120154, 74122154, 74122156, 74120156, 74120158, 74122158, 74122160, 74120160, 74120162, 74122162, 74122164, 74120164, 74120166, 74122166, 74122168 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Smith & Nephew Surgical Ltd Unit A 36 Hillside road Wairau Valley AUCKLAND 0760 |
| Contact Information: | 0800 657 799 |
| Manufacturer: | Smith & Nephew Orthopaedics Ltd |
| Brand Name: | S&N Birmingham Hip Resurfacing (BHR) Dysplasia Cup |
| Model: | 74120246, 74122248, 74120250, 74122252, 74120254, 74122256, 74120258, 74122260, 74120262, 74122264, 74120266 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Smith & Nephew Surgical Ltd Unit A 36 Hillside road Wairau Valley AUCKLAND 0760 |
| Contact Information: | 0800 657 799 |
| Manufacturer: | Smith & Nephew Orthopaedics Ltd |
| Issue: | Smith & Nephew has updated the Instructions for Use of the BHR System to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data. If a patient from the following population sub-groups is implanted with a BHR System, the patient is at greater risk of requiring a revision surgery earlier than expected: * Females * Males aged 65 or greater * Patients requiring an implant head size < 48mm Patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarges bursae, pain and swelling local buildup of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. |
| Recall action type: | Alert |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 5/2/2015 |
